BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

    MDR report key: 6277238 · Received January 25, 2017

    Report

    Report Number
    2520274-2017-10274
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Report Date
    January 4, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING THIS EVENT AND THE REPORTED DEVICES HAS NOT BEEN RECEIVED FROM THE REPORTING FACILITY AS OF THE SUBMISSION DATE OF THIS REPORT. THE 510(K): THIS REPORT IS FOR AN UNKNOWN RADIAL STEM. PART NUMBER, LOT NUMBER AND QUANTITY (ONE OR TWO DEVICES) ARE UNKNOWN. OTHER NUMBER¿UDI: PART NUMBER UNKNOWN, EXPIRATION DATE UNKNOWN, UDI IS UNAVAILABLE. POTENTIAL PART NUMBERS MAY BE: PART NUMBER 04.402.008S, BRAND NAME 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE, COMMON NAME PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER, (B)(4), 510(K) K112030; OR PART NUMBER 04.402.009S, BRAND NAME 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE, COMMON NAME PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER, (B)(4), 510(K) K112030. (B)(6). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. G5 510(K): UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS CONFIRMED THAT ALL IMPLANTS WITHIN THE SYNTHES RADIAL HEAD PROSTHESIS SYSTEM ARE BEING WITHDRAWN VIA A MARKET WITHDRAWAL. THESE PARTS ARE SUBJECTED TO DELIVERY STOP AND THE PARTS ARE CONSEQUENTLY BLOCKED IN THE SYSTEM. IN ADDITION, ON 30 DECEMBER 2016 SYNTHES (B)(4) HAS INITIATED A VOLUNTARY MEDICAL DEVICE REMOVAL (RECALL) OF THE DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM DUE TO THE POSSIBILITY THAT THE RADIAL STEM MAY LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE ((B)(4)). THE REPORTED PARTS ARE NOT RETURNED. NO FURTHER INVESTIGATION COULD BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBERS ARE NOT KNOWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE RADIAL HEAD PROSTHESIS LOOSENED POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN RADIAL STEM. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS STEM LOOSENING; HOWEVER PATIENT HAS NO PAIN AND NO PROBLEMS. NO FURTHER STEPS ARE INDICATED SO FAR AND NO REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59155 PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1